RecruitingNCT06923150

A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients


Sponsor

Qufora A/S

Enrollment

78 participants

Start Date

Jun 18, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small, low-volume bowel irrigation device (Qufora IrriSedo MiniGo) versus standard conservative treatment for people who have Low Anterior Resection Syndrome (LARS) after rectal cancer surgery. LARS causes bowel problems like urgency, leakage, and frequent trips to the toilet. **You may be eligible if...** - You are 18 or older - You had rectal cancer treated with low anterior resection surgery (colon reconnected, not a permanent stoma) - It has been 3 to 18 months since your surgery or stoma reversal - Your LARS symptoms are significant (score ≥ 25 on the LARS scale) - You have already tried at least 1 month of conservative treatments (diet, medications, etc.) - You are physically and mentally capable of operating the device yourself **You may NOT be eligible if...** - There are signs of anastomotic leakage or significant narrowing at the surgical site - Your rectal cancer has come back - You have had a permanent stoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(9)

CHU Amiens-Picardie

Amiens, France

CHU Besançon

Besançon, France

Clinique Tivoli-Ducos

Bordeaux, France

CHU Grenoble

La Tronche, France

CHU Timone

Marseille, France

CHU de NANTES, Hôtel Dieu

Nantes, France

CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE

Pessac, France

CH Lyon Sud

Pierre-Bénite, France

CHU Charles Nicolle - Rouen

Rouen, France

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NCT06923150


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